The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Device Description

The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications. The screws consist of either three or four components: head, platform, body (thread) or moreover neck.

AI/ML Overview

The provided text describes a 510(k) summary for PSM LOMAS / BENEFIT Screws, a type of orthodontic mini-anchor system. It details the device description, indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. However, the document does not provide specific acceptance criteria or details about a study proving the device meets those criteria.

The "Performance data" section only lists the types of tests performed:

Breakage and Fatigue Tests
Material Tests
Validation Tests of sterile barrier system and packaging system
Sterilization Validation Tests
Microbiological Test for determination of microorganisms
Several Clinical Justifications and Studies

It does not provide:

A table of acceptance criteria and the reported device performance: The document mentions tests were performed but does not list specific criteria or the results against them.
Sample size used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present, as no specific performance study with a test set is detailed.
Adjudication method for the test set: Not applicable as a performance study involving a test set and ground truth is not detailed.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for this type of medical device (physical screw vs. diagnostic AI).
If a standalone performance study was done: The document states "Several Clinical Justifications and Studies" were performed but does not describe the methodology or results of any such standalone study.
The type of ground truth used: Not applicable as specific performance studies involving ground truth are not detailed.
The sample size for the training set: Not applicable as this is not an AI/ML device where a training set would be relevant in the traditional sense. The "training" here would be related to engineering design and material science.
How the ground truth for the training set was established: Not applicable.

In summary, the document states that various tests and studies were performed to support substantial equivalence but does not provide the detailed information requested regarding specific acceptance criteria and the evidence proving the device meets them. The filing primarily relies on demonstrating equivalence to predicate devices based on technical characteristics, indications for use, material, target population, performance, safety, effectiveness, and biocompatibility.

Summary

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510(k) Summary

510(k) Summary as required by section 807.92(c)

Submission Applicant:

psm Medical Solutions Moltkestrasse 41 78532 Tuttlingen / Germany : Phone: +49 7461 96637-0 Fax: +49 7461 96637-29 E-mail: info@@psm.ms

Establishment Registration Number:

3008323540

Application correspondent/Contact person: think!

Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen / Germany

Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz

Trade name: PSM LOMAS / BENEFIT Screws

Common name:

. .

Root-form endosseous dental implants, Orthodontic endosseous dental implant

Classfication name:Endosseous dental implant, Dental -21 CFR 872.3640

Product Code: OAT

Predicate Devices:

Lin/Liou Orthodontic Mini Anchor System (LOMAS) K042345 and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) K050257 - manufactured by: Mondeal Medical Systems GmbH.
Syntec Orthodontic Mini Screws K090476 manufactured by Syntec Scientific Corporation
IMTEC Sendax MDI ORTHO K023067 made by IMTEC Corporation
MDI ORTHO K042289 made by IMTEC Corporation

KING 392

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Image /page/1/Picture/1 description: The image shows a logo for "psm MEDICAL SOLUTIONS". The letters "psm" are in a stylized font, with the "p" in lowercase and the "s" and "m" in uppercase. The words "MEDICAL SOLUTIONS" are in smaller, uppercase letters below the "psm".

Description of the Device:

The screws consist of either three or four components: head, platform, body (thread) or moreover neck.

Indications for Use:

Technological characteristics compared to the Predicate Devices:

The PSM LOMAS / BENEFIT Screws are similiar to the Predicate Devices Lin/Liou Orthodontic Mini Anchor System (LOMAS), Syntec Orthodontic Mini Screws, and IMTEC MDI ORTHO in terms of technical characteristics, Indications for Use, material, target population, performance, safety, effectiveness and biocompatibility characteristics. Moreover the design and sizes of the new device are strongly identical with the predicates. Therefore the PSM product can be deemed substantially equivalent for its indicated use.

Performance data:

On the PSM LOMAS / BENEFIT Screws were performed Breakage and Fatigue Tests, Material Tests, Validation Tests of sterile barrier system and packaging system, Sterilization Validation Tests. Microbiological Test for determination of microorganisms, and several Clinical Justifications and Studies.

Summary

, " .

The information submitted demonstrates the PSM LOMAS/BENEFIT Screws are substantially equivalent to predicate orthodontic anchorage screws.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is oriented to follow the curve of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

PSM MEDICAL SOLUTIONS C/O Ms. Andrea Pecsi THINK! SCHWARZWALDSTRASSE 5 TUTTINGEN BW GERMANY 78532

DEC 1 4. 2011

Re: K110392

Trade/Device Name: PSM LOMAS / BENEFIT Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 5, 2011 Received: December 8, 2011

Dear Ms. Pecsi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Pecsi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony V. Mann

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number (if known): K110392

Device Name: PSM LOMAS / BENEFIT Screws

. '

Indications for Use:

X Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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ﺎ ﺗﺄﺗﻴﻨﺎ ﻓﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ··

Suen Ruoor

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K160392

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.